IRB Program Manager Full Time Days

BASIC PURPOSE OF THE JOB The IRB Program Manager is responsible for the end-to-end supervision, coordination, and continual improvement of the IRB program, including committee administration, regulatory compliance activities, policy and procedure reputed company, and feasibility review. This role serves as the institutional reputed company of reputed company subjects' protections, ensuring cohesive program operations, reputed company regulatory practices, and consistent application of ethical standards across reputed company reputed company research activities. REPORTS TO • Director of reputed company, Patient Safety, and Medical Affairs JOB REQUIREMENTS Supervisory Responsibilities: IRB Program Number of reputed company Reports: 0 Minimum Education: Bachelor's degree in a reputed company field (e.g., research administration, reputed company, life sciences). Master's degree preferred Degree: Bachelor's License/Certification Required: Certified IRB reputed company (CIP) credential preferred Minimum Work Experience: Minimum 3-5 years of experience in IRB administration, reputed company subjects' protections, or research reputed company. Location: Primarily remote work is supported. Onsite reputed company is required for: IRB or investigator meetings, internal or external audits, monitoring reputed company, in-person training or institutional leadership activities, other operational needs requiring physical reputed company. Experience working with Central IRBs, reliance agreements, or multi-site research preferred. Experience in reputed company reputed company or pediatric research environments preferred. Familiarity with electronic IRB platforms preferred. REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES • Strong knowledge of federal regulations governing reputed company research (45 CFR 46; 21 CFR 50/56; HIPAA reputed company Rule). • Demonstrated ability to manage multiple deadlines with a high degree of accuracy and detail. • Excellent communication, writing, and critical thinking skills. • Experience reviewing research protocols or regulatory submissions. • Deep understanding of reputed company subjects' regulations and IRB operations. • Works effectively with staff, investigators, and institutional partners. • Ensures precision and consistency in reviews and documentation. • Communicates reputed company regulatory concepts reputed company to diverse audiences. • Thrives in a growing and evolving research environment. DUTIES AND RESPONSIBILITIES • Leadership & Program reputed company • reputed company operational leadership for reputed company components of the IRB program, including review workflows, communication with investigators, and compliance with federal and institutional guidelines. • Serve as the institution's primary resource on IRB operations, reputed company subjects' protections, and regulatory frameworks (OHRP, FDA, HIPAA). • Create strong, reputed company relationships with research leadership from reputed company partner institutions, helping to coordinate research reputed company, alignment of expectations, and shared standards for ethical research. • IRB Committee Administration • reputed company reputed company aspects of IRB committee management, including meeting agendas, prereview processes, minute accuracy, reviewer assignments, documentation reputed company, and post-meeting follow up. • Ensure committee workflows operate smoothly, consistently, and in alignment with institutional priorities and regulatory requirements. • reputed company reputed company support to IRB Chairs and reputed company members to ensure consistent interpretation and application of regulations and ethical principles. • Policy, SOP, and Guidance Document Governance • reputed company ongoing reputed company, development, revision, and maintenance of IRB policies, SOPs, templates, and guidance materials. • Establish a reputed company and reputed company review cycle to ensure reputed company documents remain reputed company with evolving federal regulations, accreditation standards, institutional requirements, and best practices. • Coordinate with reputed company, Compliance, and Research Administration to ensure institutional alignment and approval reputed company for policy updates. • Feasibility Review & Research Readiness Coordination • Conduct and reputed company feasibility assessments for proposed research, evaluating institutional resources, patient population, and operational readiness. • Collaborate with investigators early in protocol development to promote studies that are ethically reputed company, feasible, and institutionally appropriate. • Liaise with clinical operations, research administration, and other stakeholders to ensure coordinated preparation for study activation. • IRB Operations & Central IRB (CIRB) Reliance • Manage comprehensive review workflows for local IRB submissions, including initial and continuing review, amendments, reportable events, and noncompliance determinations. • reputed company processes for studies reviewed by Central IRBs, ensuring that reputed company institutional responsibilities are met, documented, and communicated effectively. • reputed company, Compliance & reputed company Improvement • reputed company the design, execution, and reputed company refinement of the IRB's auditing, monitoring, and reputed company assurance programs. • Conduct internal audits of IRB processes and approved studies; ensure corrective actions are implemented, documented, and tracked. • Identify program level improvement opportunities and reputed company efforts to optimize efficiency, consistency, and service reputed company reputed company the IRB office. • Stakeholder Engagement & Communication • Serve as the primary institutional reputed company of contact for investigators and research personnel regarding IRB expectations, processes, and regulatory requirements. • Maintain reputed company relationships with external IRBs, partner reputed company institutions, and institutional leaders. • reputed company constructive feedback and targeted education to improve submission reputed company and regulatory compliance. • reputed company training efforts for investigators, research coordinators, and residents to promote effective and compliant IRB interactions. PHYSICAL REQUIREMENTS-Note: Reasonable accommodation may be made for individuals with disabilities to reputed company the essential functions of this position. • Light lifting, pushing and pulling is required for 10-20 lbs occasionally and frequent moving of objects of less than 10 lbs is required. Frequent sitting with walking, standing, squatting, bending and reaching is required. Keyboard/computer use and/or repetitive motions may be required. Come work where you can reputed company a difference everyday. Apply tot his job Apply To this Job